TERBINAFINE 250 MG TABLETS - patient leaflet, side effects, dosage

Terbinafine 250mg Tablets

Terbinafine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

I Keep this leaflet. You may need to read it again

I If you have any further questions, ask your doctor or pharmacist

I This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours

I If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Terbinafine is and what it is used for

2. What you need to know before you take Terbinafine

3. How to take Terbinafine

4. Possible side effects

5. How to store Terbinafine

6. Contents of the pack and other information

1. what terbinafine is and what it is used for

Terbinafine 250mg Tablets (hereinafter refer to as Terbinafine) belong to a family of medicines called antifungals. They are used in the treatment of a variety of fungal infections of the skin and nails. Terbinafine attacks and kills the fungus which is causing your infection.

2. what you need to know before you take terbinafine

Do not take Terbinafine:

• ■ if you are allergic to terbinafine or any of the other ingredients of Terbinafine Tablets (listed in section 6)

• ■ if your have or have had any liver problems

Warnings and precautions

Talk to your doctor or pharmacist before taking Terbinafine, if you have or have had:

• ■ any liver problems or have had any diseases which may affect your liver

• ■ psoriasis or other skin disorder

• ■ any kidney problems

• ■ systemic lupus erythematosis (SLE)

• ■ a rash due to a high level of a specific type of white blood cells

Stop taking Terbinafine and talk to your doctor immediately if you experience severe itching of the skin, persistent nausea, loss of appetite, vomiting, abdominal pains or pass dark colour urine or pale coloured stools.

Other medicines and Terbinafine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.

• ■ rifampicin for infections

• ■ cimetidine for gastric problems such as indigestion or ulcer

• ■ antidepressants including tricyclic antidepressants, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors)

• ■ oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients)

• ■ beta blockers or anti-arrhythmics (including digoxin) for heart problems

• ■ medicines to treat fungal infections e.g. fluconazole, ketoconazole

• ■ medicines to treat coughs e.g. dextromethorphan

• ■ warfarin, a medicine used to thin your blood ■ medicines to treat heart problems (e.g. propafenone, amiodarone)

• ■ ciclosporin, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs

• ■ caffeine.

You should have blood tests before and during treatment with Terbinafine Tablets to monitor liver function.

Taking Terbinafine with food and drink

Swallow your tablets whole with a glass of water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant, think you may be pregnant or are breast-feeding your baby, you should not take Terbinafine.

Driving and using machines

If you feel dizzy while taking Terbinafine you should not drive or operate machinery.

3. how to take terbinafine

Always take Terbinafine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet (250mg) a day taken whole with a glass of water.

For skin infections Terbinafine 250mg Tablets are usually taken for 2 to 6 weeks. For nail infections treatment usually lasts between 6 weeks and 3 months although some patients with toenail infections may need to be treated for 6 months or longer.

Terbinafine 250mg Tablets are not recommended for children.

If you take more Terbinafine than you should

Tell your doctor or pharmacist and go to your nearest casualty department immediately.

If you forget to take Terbinafine

If you forget to take a tablet, take one as soon as you remember. Do not take a double dose to make up for a forgotten dose.

(continued overleaf)

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everbody gets them.

Some side effects can be serious

Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:

• ■ Yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems), increase in liver enzymes which may be noted on a blood test result

• ■ Severe skin reactions including rash, light sensitivity, blistering or wheals

• ■ Weakness, unusual bleeding, bruising, abnormal pale skin, unusual tiredness, or weakness or breathlessness on exertion or frequent infections (this may be a sign of blood disorders)

• ■ Difficulty breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions)

• ■ Symptoms such as rash, fever, itching, tiredness or if you notice appearance of purplish spots under the skin surface (signs of blood vessel inflammation)

• ■ Severe upper stomach pain which spreads to the back (possible signs of pancreas inflammation)

• ■ Unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)

The most common side effects are:-

• ■ Headache

• ■ Stomach problems such as loss of appetite, ache, indigestion, feeling bloated or sick

• ■ Diarrhoea

• ■ Itching, rash or swelling

• ■ Pains in the muscles and joints

The side effects listed below have also been reported.

Up to 1 in 100 people have experienced:

Taste loss and taste disturbance. This usually disappears within several weeks after you stop taking the medicine.

However, a very small number of people, (less than 1 in 10,000), have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight. There have also been reports of some people experiencing anxiety or symptoms of depression as a result of these taste disturbances.

Up to 1 in 1000 people have experienced:

• ■ Feeling unwell, dizzy

• ■ Numbness or tingling

Up to 1 in 10,000 people have experienced:

• ■ Feeling tired

• ■ Decrease in the number of some blood cells. You may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual

• ■ Psoriasis like skin eruptions, or worsening of any psoriasis including a rash or eruption of small pus containing blisters

• ■ Vertigo

• ■ Hair loss

• ■ Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints)

5. how to store terbinafine

Keep your tablets out of the sight and reach of children. Do not use the tablets after the expiry date on the product packaging.

The product does not require any special storage conditions within Europe.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat terbinafine containsthe tablets contain the active ingredient terbinafne hydrochloride equivalent to 250mg terbinafne. the tablets also contain the following inactive ingredients: magnesium stearate, colloidal anhydrous silica, hypromellose, microcrystalline cellulose and sodium starch glycolate.

What Terbinafine looks like and contents of the pack

Terbinafne Tablets are available in packs containing 14 and 28 tablets.

Marketing Authorisation Holder

Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.

Manufacturer

Manx Healthcare Ltd, Taylor Group House

Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.

This leaflet was last revised in November 2018

WIP URN: 291018-GT01-PIL-01